Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2025-12-25 @ 12:31 AM
NCT ID:
NCT01395667
Eligibility Criteria:
Inclusion Criteria:
* Biopsy proven adenocarcinoma of the rectum located up to 15 cm from the anal verge on flexible endoscopy
* Patient evaluated by surgeon and found to be a potential surgical candidate. Since the objectives are response to chemoradiation and acute toxicity, lesions which are initially unresectable are eligible-provided the surgeon feels that, if there is sufficient response, surgery could become feasible
* Clinical evidence of T3 or T4, N0-N2 and M0 disease. This can be by imaging studies (transrectal ultrasound or MRI) or by physical findings (tethering on palpation for T3 lesions or invasion of a neighboring organ for T4 lesions)
* Karnofsky Performance Status \>70
* Laboratory criteria: Absolute neutrophil count \> 1.5 K; Platelets \> 100 K; Total Bilirubin \< 2.0; aspartate aminotransferase (AST) and Alkaline Phosphatase \< 2 x upper limit of normal; Creatinine \< 1.5; Hemoglobin \> 8.0; international normalized ratio (INR): \< 1.5
* Hepatitis B (HBsAg+) or hepatitis C virus (anti-HCV Ab+) carrier status (anti-viral agents allowed if clinically needed)
* Informed consent signed
Exclusion Criteria:
* Pregnant women, patient's age \< 20 years or \> 70 years, or patients unable to give informed consent
* Patients with a past history of pelvic radiotherapy
* Patients with any other malignancy within the past 5 years except: skin cancer or in-situ cervical cancer
* Patients with known allergy/intolerance to 5-FU, Leucovorin, Oxaliplatin, Bevacizumab
* Patients with prior chemotherapy for colorectal cancer
* Patients with grade \> 2 peripheral neuropathy
* Patients with any condition which, in the opinion of the treating medical oncologist, renders the patient unfit for 5FU, Leucovorin, Oxaliplatin chemotherapy and bevacizumab
* Patients with evidence of bleeding diathesis or coagulopathy, INR\>1.5
* Patients who require the use of warfarin sodium \> 1 mg
* Patients with active GI ulcers, GI bleeding, or active inflammatory bowel disease
* Patients with clinically significant cardiac disease (e.g., uncontrolled hypertension \[blood pressure of \>160/90 mmHg on medication\], history of myocardial infarction or unstable angina within 12 months of registration), New York Heart Association (NYHA) Class II or greater congestive heart failure, unstable symptomatic arrhythmia requiring medication (subjects with chronic atrial arrhythmia, i.e., atrial fibrillation or paroxysmal supraventricular tachycardia) are not eligible
* Patients with a history of aneurysms, cerebrovascular accident (CVA) and arteriovenous malformations
* Patients with arterial thromboembolic events, including transient ischemic attack (TIA), or clinically significant peripheral artery disease within 6 months of registration
* Patients with serious, non-healing wound, ulcer, or current healing fracture
* Patients with a history of any type of fistula (vesicovaginal, gastrointestinal, etc) or gastrointestinal perforation
* Patients with intra-abdominal abscess within 6 months of study entry
* Patients who have had an organ transplant
* Patients with the placement of endorectal stent
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT01395667
Study Brief:
Protocol Section:
NCT01395667